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Amgen Medical Development Sr Mgr in Diegem, Belgium

Reports (at a minimum) to:

•Affiliate/Sub-Regional Medical Director (Direct)

•International TA Head (Indirect)

Responsible for:

•Being the single point of accountability for all Affiliate/Sub-Regional TA activities

•Driving the data generation, establishing and communicating the strategy for the Affiliate Sub-Regional TA

•Developing goals and tactics for the Affiliate/Sub-Regional TA

•Managing resources and budget for the Affiliate/Sub-Regional TA; forecast accuracy within area of responsibility

•Directing Affiliate/Sub-Regional Medical Advisors in navigating products through internal governance and external regulatory portals

•Assisting Affiliate/Sub-Regional Medical Advisors in interactions and communication with external customers, key organizations, and institutions

•Assessing risk and identifying issues, conflicts or gaps (Affiliate/Sub-Regional) across the portfolio

•Hiring, coaching, mentoring and developing staff and team members

•Ensuring Affiliate/Sub-Regional TA goal accountability

Key activities

•Provide leadership and strategic direction to the Affiliate/Sub-Regional TA staff

•Assist the IML in identifying and resolving clinical/scientific issues

•Perform portfolio level risk assessments and prioritization of programs

•Ensure alignment of early-stage strategy with late-stage TA objectives

•Approve Affiliate/Sub-Regional TA plans, goals, proposals and deliverables, including but not limited to protocols and SAP’s for local AST’s

•Chairs Affiliate/Sub-Regional TA Team meeting

•Foster and improve International collaboration and coordination

•Serve as a key interface to communicate Internationally and Locally important issues and status of programs to Amgen IRD and Affiliate/Sub-Regional Management

•Partner with the Affiliate/Sub-Regional Business Unit for all product lifecycle management activities

•Provide input, review, approve the Affiliate/Sub-Regional lifecycle management plan and ensure alignment across the portfolio

•Provide scientific/clinical oversight for the compilation of regulatory submissions across the portfolio

•Chairs the Local Development Team (LDT)

•Member of the International Development Team (IDT)

•Extended member of the International Business Team (IBT)

•Provide clinical oversight of product safety evaluation within the Affiliate/Sub-Regional TA

•Provide support and leadership for advisory boards

•Set Affiliate/Sub-Regional TA goals and dashboards to evaluate performance

•Ensure adequate resources and budget across all programs (study and non-study) and maintain budget accountability

Decision Making authority

•Direction, activities, and resource allocation within Affiliate/Sub-Regional TA

•Integrated portfolio evidence generation and communication plan

•Clinical content of Local regulatory agency briefing documents, submissions, and interactions (portfolio level)

•Clinical content of Local documents, submissions and interactions with all statutory agencies

Sign-off at signature authority level

Outputs

•Affiliate/Sub-Regional TA lifecycle management plans and medical sections of regulatory documents

•Affiliate/Sub-Regional TA goals, objectives, and performance metrics

•Sr. Management portfolio status reports and dashboards

•Sub-Regional TA budget

Qualifications

•Medical Degree (MD)

Experience

•6 or more years of clinical development experience, 4 years of which should be from a pharmaceutical or biotechnology company

•Clinical research experience

•Broad and formal leadership experience

Knowledge

•In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

•In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials

•Medical knowledge in the relevant therapeutic area

•Sound scientific and clinical judgment

•Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups

•Knowledge of Good Clinical Practices (GCP), EMEA regulations and guidelines, and applicable international regulatory requirements

•Understanding of new drug commercialization and business practices

•Understanding of resourcing and budgeting

•Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment

•Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

•Demonstrated ability to organize and lead expert Clinical Research Advisory Panels

•History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

Competencies

•Decision Making

•Scientific/Technical Leadership

•Problem Solving

•Departmental Leadership

•Written and Oral Communication

•Innovation

•Initiative

•Delivery Focus

•Team Leadership

•People management

•People motivation

•Fluency in English/Dutch/French

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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